NCT01136902

Brief Summary

The overall objective is to investigate, whether retinal blood vessel diameter change during the energy consuming dark adaptation process and if responses vary between low and high blood glucose.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

June 1, 2010

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 4, 2010

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

December 8, 2010

Status Verified

December 1, 2010

Enrollment Period

10 months

First QC Date

June 1, 2010

Last Update Submit

December 7, 2010

Conditions

Diabetes Mellitus

Keywords

Diabetes MellitusRetinal VesselsPhysiology

Outcome Measures

Primary Outcomes (1)

  • Vessel caliber

    1 day

Secondary Outcomes (1)

  • Blood glucose level

    1 day

Study Arms (1)

Type 2 DM

This group includes subjects diagnosed with type 2 diabetes mellitus with none or minimal diabetic retinopathy.

Dietary Supplement: Oral Glucose Tolerance Test (OGTT)

Interventions

Oral Glucose Tolerance Test (OGTT)DIETARY_SUPPLEMENT

75 g of glucose dissolved in 250 mL water.

Also known as: OGTT
Type 2 DM

Eligibility Criteria

Age17 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects with diagnosed Type 2 diabetes mellitus with none or minimal diabetic retinopathy.

You may qualify if:

  • Type 2 diabetic individuals.
  • minimal or no diabetic retinopathy defined by no more than five microaneurysms or dot hemorrhages per eye on three non-stereoscopic 50 degree color fundus photographs

You may not qualify if:

  • Test individuals with significant cataract, prior surgery to the eye, diabetic retinopathy, other serious eye disease, hypertension, other serious systemic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Copenhagen University Hospital at Glostrup

Copenhagen, Copenhagen, DK-2600, Denmark

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Venous blood sample. Na+, K+, Crea, HbA1c. Capillary glucose measurement. Samples will be analysed and destructed according to normal laboratory practice at the Glostrup Hospital.

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Glucose Tolerance Test

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical AnalysisClinical Chemistry TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, EndocrineInvestigative Techniques

Study Officials

  • Stig K Holfort, MD

    Glostrup University Hospital, Copenhagen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 1, 2010

First Posted

June 4, 2010

Study Start

August 1, 2009

Primary Completion

June 1, 2010

Study Completion

September 1, 2010

Last Updated

December 8, 2010

Record last verified: 2010-12

Locations

DK(1)